Welcome to GCP-Service International!

Our clients profit from our longterm strategy, which is shown in our repeat business rate of nearly 100%. GCP-Service is a privately owned full-service CRO. Since its foundation in 2004, the company has grown to a size that enables it to deliver all required services, while maintaining high flexibility and minimising overhead costs. This provides GCP-Service with the scope to conduct a wide variety of clinical studies, meeting the individual and specific needs of our clients.

Andreas Grund PhD

We do not want to be the biggest CRO, but we want to be the best CRO, which provides the highest value to our clients! Our clients are organizations that believe that “people are working with people”, not just “companies with companies”.

Mission

GCP-Service is a privately owned independent full service CRO.
We are convinced that the multiple innovative processes as well as competence and continuous development of our employees provide unique advantages during the conduction of clinical studies to our company, clients, partners and vendors.

Our daily business is based on our company values:

✓ Respect, acceptance and tolerance are the basis of a positive working environment

✓ We think that trust builds sustainability, stability and creativity

✓ We reach a high grade of satisfaction by our flexibility

✓ Reliability must be the basis of a service provider

✓ Fair and honest interactions are the basis of our interpersonal relationships

✓ Continuous professional and personal development enables us to achieve and exceed expectations

Our values are our strengths providing the basis of our success and the success of our clients, partners and vendors.

Jiri Paseka MD

Everyday living of our company values makes our team strong and self-confident. Such teams master win-win strategies and create the highest value for clients and business partners.

Service Strategy

GCP-Service offers its services via two different service provider models, depending on the needs of the client.

Full Service Model (FS Model)

Our team is capable to provide all services for the conduction of a clinical study under one roof. For companies that do not have the expertise and or manpower to conduct clinical studies on their own, GCP-Service can deliver full service support. The advantage is that the sponsor does not need to find any additional vendor, has less vendor qualification and vendor management costs and has one key point of contact. Short paths of internal communication and the close contact to the customer ensure effective and resource saving processes. Our full service is not limited to any region, medical indication or service types.

Functional Service Provider Model (FSP Model)

This model works well for organizations that mainly have their own capabilities but need support with particular project tasks like clinical monitoring in a specific region, Data Management Services, Biostatistics, EDC or Safety processes. GCP-Service provides all services also on demand. Our staff is used to work according to client SOPs within the FSP model.

Innovations

Companies developing innovative products need innovative CROs. This demand is our credo. Our team of scientists, medical doctors and programmers never considered tradition as synonym for correctness. Our clients get the best of our human skills and the best innovative software tools to run clinical studies morecosteffective, more solid and more transparent.

GCP-Service has developed a Quality Controlled Trial Management System (QCTMS), which offers much more than other comparable systems. QCTMS is an effective risk management tool in accordance with the amended ICH E6 (R2).

The use of QCTMS not only improves quality effectively, but also saves resources by saving man-power. See our QCTMS video..

Quality Controlled Trial Management System (QCTMS®)

is a flexible system which can be specifically adapted to each clinical study, sponsor or SOP. Individual tolerance alert level can be specified to initiate preventive actions, or as an audit trigger to initiate corrective and preventive actions at the first sign of their occurrence. Typical parameters, such as informed consent process, SAE reporting timelines, recruitment rates, query rates, number of protocol deviations, monitoring frequency, statistical parameters and many additional factors, can be used to evaluate the risk with regards to data quality, or risks affecting study subjects. Different risk levels trigger automatic alerts to your Project Management and/or Quality Assurance department.

QCTMS® IRT (Interactive Response Technology)

GCP-Service has developed QCTMS IRT to sponsors and CROs to use web based randomization or drug assignment solution in a simple and extremely cost effective way.
The interactive response technology of QCTMS® IRT allows centralized web-based randomization and drug assignment in an extremely user friendly way. We know that site personnel are normally not very comfortable in sophisticated IT environments; this fact alone allows us to develop a simple, easy-to-use electronic tool ensuring compliance by every user.
The advantages of QCTMS IRT are:

• Flexible system which can be used for every study design
• Up to 5 stratification parameters in one trial
• Easy to use, intuitive and user-friendly
• Connection to QCTMS for quality control of randomization data
• Controlled code break option
• 21 CFR Part 11 compliant

QCTMS® EDC (Electronic Data Capture)

QCTMS® EDC allows physicians, researchers and their personnel to specifically and individually capture the research data to be acquired and to analyze them in a standardized manner. Our EDC system provides the following features and benefits:

Our EDC system is extremely cost effective which makes it a useful tool even for clinical studies with a small number of patients. The combination of our EDC with our Clinical Trial Management System (QCTMS) improves quality but also saves money by saving man-power. After a very short time, project teams are able to recognise the benefit of these unique systems.

QCTMS® ePRO (electronic Patient Reported Outcome)

This smart and easy-to-use tool allows centralized data entry for patient diaries and questionnaires in a user friendly way. We know that patients in clinical trials are often not familiar with IT environments. Therefore we developed a simple electronic tool ensuring compliance by every user. QCTMS® ePRO allows study subjects to capture the trial data in a fast and error-free way and provides the site staff with the required oversight. Integrated control functions save manual queries and ensure a higher data quality and integrity.
The main features of the QCTMS® ePRO are the following:
• Timely and rapid data acquisition and reporting
• Integrated data check for completeness and plausibility
• Individually configurable roles and authorizations
• Overall data quality improvement
• Available in all languages
• Cost effectiveness

ePRO Example design

ePRO "visit" overview

ePRO questionaire

ePRO Visual Analog Scale

Global Coverage

We have experience in conducting clinical trials with medical device and pharmaceuticals in the following regions of the world:

USA/LATIN AMERICA

MENA

Israel

AFRICA

South Africa

ASIA

Japan, China

Australia

Australia, New Zealand

For our clients it is usually not the best solution to contract a global CRO, due to different company cultures and different values. In order to offer a real alternative solution for our small to midsize clients, founded in 2013 the Association of International CROs (AICROS) which is a registered, ISO9001 certified alliance of small to midsize CROs which provide clinical research services for the medical device, pharmaceutical and biotech industry for many years. The AICROS members pay membership fees to be part of AICROS which shows the high intrinsicmotivation and commitment to international trials. Because of such a cluster of experience and expertise AICROS members know the needs of sponsors exactly. We have an ability to conduct international trials like a global CRO but give sponsors a whole range of advantages of smaller CROs. This situation ensures the perfect match for a long-term partnership between sponsor and CRO.

With our AICROS members the GCP-Service team conducts multinational trials in Asia, Latin-America, USA, Africa and Europe.

Dynamic History

2018 GCP-Service and Leading Clinical Research merge

In order to offer our clients high quality services all over Europe, GCP-Service and the Central European CRO with the headquarter in Prague Leading Clinical Research (LCR) merge to GCP-Service International.

2017 Global Coverage

Since the foundation of GCP-Service, we have conducted more than 300 clinical studies in more than 20 countries, with more than 50 products, in more than 30 medical areas and we have trained more than 5000 investigators in the quality standards of clinical trials. We have passed several sponsor audits and regulatory inspections incl. FDA inspections without any problems. However, the most important fact which makes our team proud is our extremely high repeat business rate of nearly 100%, which shows that people worldwide rely on us and have trust in our services.

2016 Launching QCTMS ePro

In order to offer the complete range of modern EDC tools to ensure better data quality and data integrity, the GCP-Service team developed an own ePro system called “QCTMS-ePro”. By using ePro, study subjects can report data directly in a much more comfortable and reliable way. However, many ePro solutions have been programmed by software developers, who do not know or poorly understand the needs of the users/patients. Our ePro was developed in a way that it can be easily used by study subjects on their own mobile devices or computers which they know best, thereby ensuring highest patients compliance.

2016 Launching QCTMS ISF

Motivated by the success of the eTMF module of QCTMS, the electronic Investigator Site File “QCTMS eISF” has been launched. This tool allows our team to maintain and control 90% of the ISF documents centrally, which saves costs and time for clinical monitoring.

2015 Opening own Product Safety Department

The management team of GCP-Service recognized that the safety processes within clinical studies are extremely ineffective. Paper based reports, reported by fax machines and data gaps of such critical data caused delays in the reporting processes to the competent authorities. This unacceptable situation was the reason for GCP-Service to open its own product vigilance department, which works 100% electronically. Our product safety staff use highly effective tools which lead to solid and reliable reported safety data.

2015 Launching QCTMS TMF

After the publication of the EMA reflection paper about TMF within clinical studies, it is required by competent authorities that TMFs are always inspection ready, independent of the study size. Knowing that the reality looks completely different, the GCP-Service team was keen on complying with this requirement and launched the QCTMS module “QCTMS TMF”, which is a validated electronic TMF complying 100% with the requirements of the competent authorities. Beside a better compliance with the requirements of the EMA reflection paper, our team recognized quickly how much more effective the electronic set-up and maintenance of an eTMF is.

2014 Launching QCTMS IRT

The electronic randomization tool QCTMS IRT was launched in 2014. Like all other QCTMS modules, QCTMS IRT is a very solid and easy-to-use tool to randomize or register study subjects, or to order the study products according to the needs at the study site. Again, this tool has an extreme positive effect regarding increasing data quality and data integrity, and a decreasing cost effect as the product supply can be organized very effectively.

2013 Foundation of AICROS

In order to meet the demands for the conduct of global studies, GCP-Service together with two partner CROs founded the Association of International CROs www.aicros.com. AICROS enables GCP-Service to conduct global clinical studies with reliable AICROS members. The AICROS CROs are located in USA, Latin America, Asia, Africa and Europe. Together, AICROS can boast of the global spread of a global CRO and yet maintain the advantages of local CROs.

2012 Launching Pi-Select

The development of the electronic feasibility tool PI-Select to run large feasibilities more effectively was necessary to receive more robust and reliable data which is the basis for the conduction of clinical studies according to a pre-defined milestone plan.

2011 Launching QCTMS EDC

Due to our focus on clients with lean structures which have the wish of running excellent studies with reliable fix budgets and the knowledge that most EDC providers are not able to offer robust and cost effective EDC solutions, GCP-Service launched its own eCRF in 2011. The new QCTMS module called QCTMS EDC enabled us to import clinical data entered by the study sites on demand, evaluate critical data and send out alerts to the study teams, if necessary.

2010 Opening own Data Management and Biostatistics Department

The opening of an own Data Management and Biostatistics department in 2010 was a logical consequence of the increasing need for full services. Automatic evaluation of critical data with QCTMS and the close connection to the University of Bremen, where a new study program “Master of Biometrics” was established and the students were partly trained by GCP-Service staff helped the process.

2010 First ISO 9001 certification

Knowing that effectiveness is as important for a service provider as quality, GCP-Service established a QM system which was ISO 9001 certified in 2010. The compliance with ISO 9001 during 2007 taught us that traditional processes are not optimized as they might be ineffective due to new technical opportunities. That is the reason why GCP-Service invested a huge amount of time, money and manpower in further development of new, innovative and cost effective electronic solutions for our team and our clients.

2009 Launching QCTMS

Due to its extremely high repeat business rate and reputation in clinical monitoring, project management and quality assurance services, the GCP-Service team has grown rapidly during the first years. The critical view on traditional clinical operation processes established at most companies caused the development of an own CTMS system which we called Quality Controlled Trial Management System (QCTMS). Launching QCTMS in 2009 was an important milestone for GCP-Service and our clients, which enabled us to start a new clinical research area. Since 2009, the GCP-Service team has been able to run multi-centre studies better, less complex and more cost effectively, leading to many new opportunities.

Due to the high demand for certified 1-day or even 2-days GCP-trainings for investigators in Germany and the lack of persons who are qualified and able to meet these requests, we launched the first CME certified GCP-Online Training in Germany which enables us to train unlimited numbers of investigators and other people involved in clinical studies at a very high standard. The training courses are accepted by the Ethics Committees which reduced the start-up phase significantly. In the meanwhile, GCP-Service is the German market leader for online GCP and ISO14155 training courses provided in many different countries to various customers in several languages.

2004 Foundation of GCP-Service International Ltd. & Co. KG

GCP-Service was founded in 2004 by Andreas Grund PhD. After gaining several years of experience in different positions in large global CROs, Andreas Grund PhD decided to start his own company with a clear focus on sponsors with lean and effective structures.